Hepatitis BNCT01263600
Hepatitis B Research Network Pediatric Cohort Study (HBRN)
An observational study of Hepatitis B, run by University of Pittsburgh at 7 sites in 2 countries.
Trial summary
The purpose of this study is to describe participants 6 months to <18 years of age with hepatitis B virus (HBV) infection in a prospective cohort in the United States (US) and Canada and identify predictors of disease activation and progression. Read more about this study
- Who is it for?
- Ages 6 months to 17 years
- Conditions the study is for
- Hepatitis B
- How many people
- 462 participants
- Where
- 7 sitesin 2 countries
- Study dates
- Dec 2010to 9 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Pediatric patients from Children's Hospitals and university medical centers in the United States and Canada
Who may be able to join
- Written informed consent/assent as appropriate
- At least 6 months to <18 years of age
- Hepatitis B surface antigen (HBsAg) positive
Who cannot join
- Hepatic decompensation
- Hepatocellular carcinoma (HCC)
- Liver transplantation
- Current Hepatitis B antiviral treatment (except pregnant females)
- Known coinfection with HIV (patients with hepatitis D or hepatitis C coinfection are not excluded)
- Medical or social condition which in the opinion of the principal investigator would interfere with or prevent regular follow up.
- Unable or unwilling to return for regular follow-up
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
United States6 sites
Johns Hopkins University
Baltimore, Maryland, 21287
University of Texas Southwestern
Dallas, Texas, 75235
University of Minnesota
Minneapolis, Minnesota, 55455
University of California San Francisco Medical Center
San Francisco, California, 94143
Seattle Children's Hospital
Seattle, Washington, 98015
Cardinal Glennon Children's Medical Center
St Louis, Missouri, 63104
About this study
Official title: Cohort Hepatitis B Virus (HBV) Pediatric Protocol
The purpose of this study is to describe participants 6 months to <18 years of age with hepatitis B virus (HBV) infection in a prospective cohort in the United States (US) and Canada and identify predictors of disease activation and progression.
Read the detailed description
•Primary Aim:
- To describe participants 6 months to <18 years of age with hepatitis B virus (HBV) infection in a prospective cohort in the United States (US) and Canada and identify predictors of disease activation and progression
Secondary Aims:
- To describe clinical, virological, and immunological characteristics of participants with HBV in the US and Canada.
- To evaluate changes in HBV infection status and hepatitis B surface antigen (HBsAg) levels and factors associated with those changes.
- To verify whether a baseline HBsAg below 1,000 IU/mL and HBV DNA below 1,000 IU/mL is an accurate predictor of people who are, or who will become, inactive carriers, defined as people who are HBsAg positive, hepatitis B "e" antigen (HBeAg) negative, have normal alanine aminotransferase (ALT) and HBV DNA under 1,000 IU/mL on at least two occasions over a period of at least 6 months with HBV DNA under 1,000 IU/mL.
- To assess the health related quality of life (HRQOL) of treatment naïve hepatitis B surface antigen (HBsAg) positive children and adolescents
- To develop a bank of biospecimens (e.g., serum, plasma, DNA, liver tissue) obtained from participants with HBV infection.
- To identify pediatric participants from 2 years to <18 years of age with chronic HBV infection for potential participation in treatment study to be conducted by the Hepatitis B Research Network (HBRN).
- Conditions
- Hepatitis B
- Keywords
- Hepatitis B, HBV, Pediatric
- Medical subject headings
- Hepatitis B
What is being measured
The primary outcome is the main question the study is designed to answer.
Antigen loss: e and s
Loss of these viral markers may be associated with appearance of corresponding antibodies in serum (anti-HBe or anti-HBs). HBsAg loss appears to represent a "cure" of HBV infection and is associated with reduction, but not necessarily elimination, of the risk of future complications, such as Hepatocellular carcinoma (HCC) which may occur, particularly in those who lose HBsAg at an older age (after 50 years) or after the development of cirrhosis. When HBeAg or HBsAg loss occurs, participants will be followed more closely initially and then return to the regular follow-up schedule.
Measured: up to 288 weeks
Secondary outcomes (7)
Hepatitis exacerbation marked by alanine aminotransferase (ALT) Flare
A flare is defined as serum alanine aminotransferase (ALT) greater than or equal to 10 times the upper limit of normal which corresponds to (1 550 IU/L in females and 600 IU/L in males for 6 months - 18 months of age and 2) 350 IU/L in females and 400 IU/L in males for >18 months - < 18 years of age (12). Once a flare is detected, participants will be followed more closely until its resolution.
Measured: up to 288 weeks
Cirrhosis
The diagnosis of cirrhosis will be made by (1) liver histology, when available or In the absence of histological diagnosis, cirrhosis is defined as any one of the following
- Presence of ascites or hepatic hydrothorax
- Variceal or portal hypertensive bleeding
- Hepatic encephalopathy
- Child-Turcotte-Pugh (CTP) score of 7 or above or in the absence of hepatic decompensation (any two of the following):
- Splenomegaly
- Nodular liver
- Platelet count below 120,000/mm3
Once cirrhosis is diagnosed, patient follow-up should include Hepatocellular carcinoma(HCC)surveillance
Measured: up to 288 weeks
Hepatic Decompensation
It is likely that the development of cirrhosis and subsequent hepatic decompensation will be preceded and foreseen by the progression of fibrosis. Development of hepatic decompensation will be defined by any of the following events:
- Ascites or hepatic hydrothorax
- Variceal bleeding or portal hypertensive bleeding
- Hepatic encephalopathy
- Child-Turcotte-Pugh (CTP) score of 7 or above
It is anticipated that there will be a small number of patients that will develop decompensation during the follow-up.
Measured: up to 288 weeks
Hepatocellular carcinoma (HCC)
HCC may be detected by routine surveillance or may become clinically apparent. The diagnosis of HCC will be made using the American Association for the Study of Liver Disease criteria.
Measured: up to 288 weeks
Death
Death may occur related to liver disease (typically hepatic decompensation or HCC) or may occur unrelated to hepatitis B or liver disease. Date and cause of death will be recorded.
Measured: up to 288 weeks
Liver transplantation
Liver transplantation will be recorded upon notification. Date of transplantation, indication for transplantation, and occurrence of incidental HCC will be recorded. Follow-up ends with liver transplantation.
Measured: up to 288 weeks
Reaching 18 years of Age
Patients who reach 18 years of age and are within an adult HBRN clinical center will be offered participation in the adult cohort study and re-consented for the adult protocol.
Measured: up to 288 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2010 (estimated)
- Study startDec 2010
- Primary completion9 Jun 2021
- Study completion9 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatitis BStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 462 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Lok, University of Michigan
- Investigators
- Steven Belle, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01263600
- Sponsor's protocol ID
- DK082864Pediatric
- Other IDs
- U01DK082916, U01DK082864, U01DK082874, U01DK082944, U01DK082843, U01DK082871, UL1TR000423, UL1TR000004
- Status last verified
- May 2022
- First submitted
- 14 Dec 2010
- Last updated
- 31 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Di Bisceglie AM, King WC, Lisker-Melman M, Khalili M, Belle SH, Feld JJ, Ghany MG, Janssen HLA, Lau D, Lee WM, Ling SC, Cooper S, Rosenthal P, Schwarz KB, Sterling RK, Teckman JH, Terrault N; Hepatitis B Research Network (HBRN). Age, race and viral genotype are associated with the prevalence of hepatitis B e antigen in children and adults with chronic hepatitis B. J Viral Hepat. 2019 Jul;26(7):856-865. doi: 10.1111/jvh.13104. Epub 2019 May 2.
PubMed 30974509
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cohort Hepatitis B Virus (HBV) Pediatric Protocol
- ClinicalTrials.gov ID
- NCT01263600
- Acronym / sponsor ID
- DK082864Pediatric
- Conditions
- Hepatitis B
- Keywords
- Hepatitis B, HBV, Pediatric
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 462 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Dec 2010
- Primary completion
- 9 Jun 2021 (actual)
- Study completion
- 9 Jun 2021 (actual)
- First posted
- 20 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to describe participants 6 months to <18 years of age with hepatitis B virus (HBV) infection in a prospective cohort in the United States (US) and Canada and identify predictors of disease activation and progression.
Detailed description
•Primary Aim:
- To describe participants 6 months to <18 years of age with hepatitis B virus (HBV) infection in a prospective cohort in the United States (US) and Canada and identify predictors of disease activation and progression
Secondary Aims:
- To describe clinical, virological, and immunological characteristics of participants with HBV in the US and Canada.
- To evaluate changes in HBV infection status and hepatitis B surface antigen (HBsAg) levels and factors associated with those changes.
- To verify whether a baseline HBsAg below 1,000 IU/mL and HBV DNA below 1,000 IU/mL is an accurate predictor of people who are, or who will become, inactive carriers, defined as people who are HBsAg positive, hepatitis B "e" antigen (HBeAg) negative, have normal alanine aminotransferase (ALT) and HBV DNA under 1,000 IU/mL on at least two occasions over a period of at least 6 months with HBV DNA under 1,000 IU/mL.
- To assess the health related quality of life (HRQOL) of treatment naïve hepatitis B surface antigen (HBsAg) positive children and adolescents
- To develop a bank of biospecimens (e.g., serum, plasma, DNA, liver tissue) obtained from participants with HBV infection.
- To identify pediatric participants from 2 years to <18 years of age with chronic HBV infection for potential participation in treatment study to be conducted by the Hepatitis B Research Network (HBRN).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 months to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Pediatric patients from Children's Hospitals and university medical centers in the United States and Canada
Key inclusion criteria (3 listed)
- Written informed consent/assent as appropriate
- At least 6 months to <18 years of age
- Hepatitis B surface antigen (HBsAg) positive
Key exclusion criteria (7 listed)
- Hepatic decompensation
- Hepatocellular carcinoma (HCC)
- Liver transplantation
- Current Hepatitis B antiviral treatment (except pregnant females)
- Known coinfection with HIV (patients with hepatitis D or hepatitis C coinfection are not excluded)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Antigen loss: e and s
Time frame: up to 288 weeks
Loss of these viral markers may be associated with appearance of corresponding antibodies in serum (anti-HBe or anti-HBs). HBsAg loss appears to represent a "cure" of HBV infection and is associated with reduction, but not necessarily elimination, of the risk of future complications, such as Hepatocellular carcinoma (HCC) which may occur, particularly in those who lose HBsAg at an older age (after 50 years) or after the development of cirrhosis. When HBeAg or HBsAg loss occurs, participants will be followed more closely initially and then return to the regular follow-up schedule.
7 secondary outcomes
Hepatitis exacerbation marked by alanine aminotransferase (ALT) Flare
Time frame: up to 288 weeks
Cirrhosis
Time frame: up to 288 weeks
Hepatic Decompensation
Time frame: up to 288 weeks
Hepatocellular carcinoma (HCC)
Time frame: up to 288 weeks
Death
Time frame: up to 288 weeks
Liver transplantation
Time frame: up to 288 weeks
Reaching 18 years of Age
Time frame: up to 288 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2022.
- Derived from this study: PubMed 30974509Di Bisceglie AM, King WC, Lisker-Melman M, Khalili M, Belle SH, Feld JJ, Ghany MG, Janssen HLA, Lau D, Lee WM, Ling SC, Cooper S, Rosenthal P, Schwarz KB, Sterling RK, Teckman JH, Terrault N; Hepatitis B Research Network (HBRN). Age, race and viral genotype are associated with the prevalence of hepatitis B e antigen in children and adults with chronic hepatitis B. J Viral Hepat. 2019 Jul;26(7):856-865. doi: 10.1111/jvh.13104. Epub 2019 May 2.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven Belle, PhD principal investigator
University of Pittsburgh
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis B, run by University of Pittsburgh at 7 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antigen loss: e and s (time frame: up to 288 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01263600, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2022.